Biologics
Reps. Debbie Dingell (D-MI) and Rich McCormick (R-GA) are calling on FDA to adopt a more effective strategy for identifying sepsis in human tissue donors. In a 5/26 letter to acting commissioner Kyle Diamantas, Dingell and McCormick say they have learned from talking with experts that screening
Devices
FDA this week marked the 50th anniversary of the 1976 Medical Device Amendments by highlighting the law’s lasting role in shaping the modern oversight of medical devices. In a new FDA Voices commentary, CDRH director Michelle Tarver said the amendments created the regulatory framework that continues to govern how
Devices
FDA has issued an update on a Philips Respironics device correction involving its Trilogy Evo platform ventilators, citing risks that could cause serious injury or death if the devices are not updated. The action affects several ventilator models in the Trilogy Evo platform, including the Trilogy Evo, Trilogy EV300, Trilogy
FDA Policy/General
FDA has extended by three months its review timeline of a Beren Therapeutics NDA for adrabetadex for treating infantile-onset Niemann-Pick disease, Type C (NPC). The new user fee review action target date is 11/17. The extension follows a 3/18 Beren response to an FDA information request
Drugs
FDA has approved AstraZeneca’s Imfinzi (durvalumab) in combination with Bacillus Calmette-Guerin (BCG) for treating adults with BCG-naïve, high-risk non-muscle invasive bladder cancer, expanding the use of the company’s immunotherapy. The approval covers patients with high-risk non-muscle invasive bladder cancer, or NMIBC, following
Drugs
Former FDA associate commissioner Peter Pitts, who is now president of the Center for Medicine in the Public Interest, has been named to the BrainStorm Cell Therapeutics board of directors. A company announcement says that once it obtains funding, BrainStorm will start its Phase 3b ENDURANCE trial evaluating NurOwn for
Biologics
FDA’s Vaccines and Related Biological Products Advisory Committee has voted 8 to 0 to recommend updating Covid-19 vaccines for the 2026-2027 immunization season to target the currently dominant XFG variant, a descendant of the JN.1 lineage that now accounts for the majority of U.S. Covid
Drugs
FDA says a 5/6-6/20/2024 Bioresearch Monitoring Program inspection of a clinical investigation conducted by Dr. Adnan Dahdul in Springfield, MA, found “objectionable conditions” in that Dahdul violated regulations governing the proper conduct of clinical studies involving investigational products. A just-released 3/12 Warning Letter says
Drugs
FDA is extending by 30 days the comment period on a request for information entitled “AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program." Earlier this year, the agency announced it was seeking comments on how AI-enabled technologies can improve efficiency, speed, and quality of decision-making
Biologics
Eli Lilly says it is acquiring three vaccine developers in deals worth up to $3.8 billion combined, expanding its push into infectious disease prevention and underscoring a renewed emphasis on vaccines following the hiring of former FDA CBER director Peter Marks late last year. Financial analysts said the acquisitions
Drugs
FDA has cited Dabur India Limited for significant manufacturing and data integrity violations at an over-the-counter drug manufacturing facility in India, according to a just-posted inspection report that detailed falsified records, questionable microbiology testing practices and sanitation problems. FDA issued a Form-483 following a 1/12-
Devices
Researchers from several universities say that low use of predetermined change control plans (PCCPs) for AI-enabled medical devices could be a missed opportunity for improving device performance. The researchers report on a cross-sectional study describing PCCP use among AI-enabled medical devices and the comprehensiveness of public reporting
Devices
FDA and federal prosecutors are signaling a tougher stance on failures to report patient safety issues to regulators, according to a new legal analysis from Cooley LLP examining the recent criminal enforcement action against medical device maker ExThera Medical Corporation and one of its former executives (see earlier story). Former
Drugs
An 11/3-11/ 7/2025 FDA inspection at the GC America drug manufacturing facility in Alsip, IL, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 5/14 Warning Letter says the specific violations were: * failure to test samples of each component for identity
Drugs
FDA has extended its review of an AstraZeneca NDA for camizestrant, an experimental breast cancer therapy, after requesting additional data tied to a closely watched Phase 3 study that has drawn scrutiny from outside advisers. The company is seeking approval for camizestrant in combination with CDK4/6 inhibitors for first-
Drugs
Corcept Therapeutics plans to resubmit its NDA for relacorilant as a treatment for patients with Cushing’s syndrome, following additional analyses requested by FDA after issuing a complete response letter late last year. The company says FDA requested further analyses of data already included in the application. Corcept CEO Joseph
Drugs
FDA has approved an AbbVie NDA for Decnupaz (pivekimab sunirine-pvzy), a CD123-directed antibody and alkylating agent conjugate for adults with blastic plasmacytoid dendritic cell neoplasm (BPDCN). The agency says the approval was based in data from the CADENZA (NCT03386513) study, a multicenter, open-label, single-arm clinical trial
Drugs
Consulting firm NSF says that how a company responds to a form FDA-483 can influence how inspection findings are classified and what steps the agency might take in the future. The firm uses an online post (includes a link to the webinar) to present the lessons learned from a
Drugs
An 11/28-12/4/2025 FDA inspection at the Alchymars ICM SM Private Limited drug manufacturing facility in Alathur, Tamil Nadu, India, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (APIs). A 5/21 Warning Letter says the specific violations were: * failure to
Drugs
An 11/13-11/21/2025 FDA inspection at the Sato Pharmaceutical drug manufacturing facility in Tokyo, Japan, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 5/18 Warning Letter says the specific violations were: * failure to establish and follow appropriate written procedures that
Drugs
The U.S. government has urged the Supreme Court to reject an appeal by a Texas compounding pharmacy in a closely watched case over whether federal drug law preempts state-law claims challenging the sale of compounded medications. In a brief filed 5/21 at the invitation of the justices,
Drugs
Outlook Therapeutics has won an appeal with FDA over its BLA for ONS-5010/Lytenava (bevacizumab-vikg), clearing a potential path toward U.S. approval of the investigational wet age-related macular degeneration treatment. The agency granted the company’s appeal following a Formal Dispute Resolution process with the agency’